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Evaluation of the effect of vitamin E in reducing the duration of treatment in children with gastroenteritis

Protocol summary

Study aim
Investigating the effect of vitamin E during the treatment of children with gastroenteritis ​
Design
Clinical trial with control and intervention group, without blinding, randomized, phase 2 on 60 patients. Block randomization method is used for randomization
Settings and conduct
Based on the inclusion criteria, the people who enter the study are randomly divided into two groups receiving vitamin E for 10 days and standard treatment (liquid therapy and ORS) and a group of patients who only receive standard gastroenteritis treatment. The duration of the disease is based on the clinical symptoms of gastroenteritis. The obtained results are recorded in the checklist prepared for this purpose. Also, this study is conducted by project managers and relevant interns. In this study, randomization, selection of patients, allocation of patients to groups in this study is done by the student himself. In addition to these drugs, the relevant doctor who is the main guide will be prescribed.
Participants/Inclusion and exclusion criteria
All children aged 1-13 years with acute gastroenteritis referred to Amirkabir Hospital, whose acute gastroenteritis was confirmed by a pediatric specialist based on the symptoms of diarrhea, vomiting, abdominal pain and dehydration. and have informed consent to participate in the study ​
Intervention groups
In addition to the routine treatment with fluid therapy, the intervention group will receive the standard daily amount of vitamin E drops from Besa company for 10 days according to the age. ​
Main outcome variables
The duration of the disease is based on the clinical symptoms of gastroenteritis, which include Diarrhea, vomiting, abdominal pain, fever and dehydration which are assessed at the beginning and end of the study

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231119060105N1
Registration date: 2023-11-25, 1402/09/04
Registration timing: registered_while_recruiting

Last update: 2023-11-25, 1402/09/04
Update count: 0
Registration date
2023-11-25, 1402/09/04
Registrant information
Name
Zeinab Saleh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 6555
Email address
z.saleh.g@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-01, 1402/07/09
Expected recruitment end date
2024-05-29, 1403/03/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of vitamin E in reducing the duration of treatment in children with gastroenteritis
Public title
Evaluation of the effect of vitamin E in reducing the duration of treatment in children with gastroenteritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All children aged 1-13 years with acute gastroenteritis referred to Amirkabir Hospital, whose acute gastroenteritis was confirmed by a pediatric specialist based on the symptoms of diarrhea, vomiting, abdominal pain and dehydration. Informed consent to participate in the study
Exclusion criteria:
Children who cannot tolerate oral vitamin E People who do not cooperate.
Age
From 1 year old to 13 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be done, for this purpose, the participants will be assigned to two intervention and control groups according to the order of arrival and based on the randomization sequence that will be generated in advance. This sequence is unpredictable and its arrangement is completely random. . Block randomization method with 8 blocks will be used to allocate the samples. In this way, using the site www.sealedenvelope.com, blocks of 8 letters A and B are randomly generated based on the sample size. The order of placement of letters A and B in each block from the first block to the last block is considered as a randomization sequence. The production of these blocks and their random sequence is completely done by this site and the researcher does not know how they are sequenced.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of medical science, Basij square
City
Arak
Province
Markazi
Postal code
8735610954
Approval date
2023-09-30, 1402/07/08
Ethics committee reference number
IR.ARAKMU.REC.1402.164

Health conditions studied

1

Description of health condition studied
gastroenteritis
ICD-10 code
A09
ICD-10 code description
Infectious gastroenteritis and colitis, unspecified

Primary outcomes

1

Description
The effect of vitamin E on reducing the duration of diarrhea, vomiting, abdominal pain, fever, anorexia and dehydration in gastroenteritis patients.​
Timepoint
The beginning of the intervention and the end of symptoms
Method of measurement
Through history and questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: intervention group In addition to routine treatment, which includes fluid therapy and ORS, receive vitamin E drops from "Bahsa" company, each milliliter of which contains 10 international units of vitamin E, for 10 days according to age as follows We use: age 1-3 years: 18 drops equal to 0.90 ml; Age 4-8 years: 21 drops equal to 1.05 ml; Age 9-13 years: 33 drops equal to 1.65 ml
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Dr. Ali Arjmand
Street address
Shahid Shiroudi St. - Nurse Square - Amirkabir Hospital
City
Arak
Province
Markazi
Postal code
3819693181
Phone
+98 86 3313 4715
Email
amirkabir-hospital@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehdi Salehi
Street address
Arak University of medical science, Basij square
City
Arak
Province
Markazi
Postal code
8735610954
Phone
+98 86 3417 3522
Email
www.salehi58@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Ali Arjmand
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Shahid Shiroudi St. - Nurse Square - Amirkabir Arak Hospital
City
Arak
Province
Markazi
Postal code
3819693181
Phone
+98 86 3313 4715
Email
Aliarjmand1@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Ali Arjmand
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Shahid Shiroudi St. - Nurse Square - Amirkabir Arak Hospital
City
Arak
Province
Markazi
Postal code
3819693181
Phone
+98 86 3313 4715
Email
Aliarjmand1@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Ali Arjmand
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Shahid Shiroudi St. - Nurse Square - Amirkabir Arak Hospital
City
Arak
Province
Markazi
Postal code
3819693181
Phone
+98 86 3313 4715
Email
Aliarjmand1@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can potentially be shared after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions, as well as people working in the industry, can apply for them
Under which criteria data/document could be used
There are no other conditions
From where data/document is obtainable
To the main person responsible for the study; Dr. Ali Arjmand can be contacted at Aliarjmand1@yahoo.com
What processes are involved for a request to access data/document
The applicant can contact the person in charge of the study through the email address and get access to the information as soon as possible after the request
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